Bipolar Disorder
Conditions
Brief summary
* To determine the total and local gray matter volumes, and N-acetyl aspartate (NAA) levels in patients with bipolar disorders who are within euthimic, depressive or manic/hypomanic period and who are not taking drug; * To investigate the neuroprotective effects of long-term (6 weeks) use of valproate on total and local gray matter volumes and NAA levels. * To measure the brain electrical response to visual and auditory impulses before and after valproate treatment in patients within euthimic, depressive or manic/hypomanic period and who are not taking drug, and to compare the data with each other and with normal groups. * To determine the cognitive functions before and after the valproate treatment in the same patient group, to compare the data with each other and with age- and sex-paired normal controls; * To determine the relationship between these effects of valproate and clinical improvement; * To investigate the relationship between cognitive ability status and electrical activity of brain, to compare this with that in control group; to determine the relationship between the data and brain imaging (MRI/MRS) findings in conjunction with localization
Interventions
DRUGValproic acid, sodium salt
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of type I or II bipolar disorder according to DSM-IV after stratified SCID I interview, * being currently euthimic (for at least one month), manic-hypomanic and having YMRS points of 15 or more, or being in depressive episode and having HAM-D21 points of 15 or more * being not taking drugs for at least two weeks before participating in the study (except benzodiazepins)
Exclusion criteria
* female who are pregnant or planning to be pregnant, nursing * having known hypersensitivity to study drug * being given any psychotropic agent other than benzodiazepine within the last two weeks * active sustance or alcohol usage within the last two weeks, or substance addiction other than cafein or nicotine (within the last month) * having another axis I disorder such as comorbid dementia, delirium, obsessive compulsive disorder, eating disorder * having unstabilised hepatic or renal disorder, thyroid or blood disease * having history of cerebral surgery * existence of a degenerative neurologic disease or epilepsy * having pacemaker * having a prosthesis able to magnetic effect in eye, brain or sites near to these regions * homicide thougths or severe catatonia required to be hospitalized * having mixed episode The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess regional N-acetyl aspartate (NAA) levels in drug free bipolar patients either in manic/hypomanic, or depressive or euthymic state | for 6 weeks |
| To investigate valporate's effect on total and regional gray matter volume and NAA levels; | for 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| To assess evoked and event related potentials to visual and auditory stimuli in patients before and after valproate monotherapy in comparison to healthy controls | for 6 weeks |
| To determine the relationship between clinical improvement and image data changes in depressed or manic/hypomanic patients, | for 6 weeks |
Countries
Turkey (Türkiye)
Outcome results
None listed